The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).
The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension. All subjects are now in long term follow-up and are required to have at least one annual visit. Parameters assessed during visits are: * Office Cuff Blood Pressure * Physical Assessment * Subject Medications * Serious adverse events
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Experimental: Device and Medical Management Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.
Arizona Heart Rhythm Research Center
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
George Washington University
Washington D.C., District of Columbia, United States
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.
Time frame: For the duration of the study, up to ten years.
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Florida Hospital
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States
Michigan CardioVascular Institute
Saginaw, Michigan, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
...and 1 more locations